Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT03503656
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Compuflo®" in Epidural Space Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'was the number of successes', 'timeFrame': '18 months', 'description': 'number'}], 'secondaryOutcomes': [{'measure': 'the number of accidental dural punctures', 'timeFrame': '18 months', 'description': 'number'}, {'measure': 'the number of attempts', 'timeFrame': '18 months', 'description': 'number'}, {'measure': 'procedure time duration', 'timeFrame': '18 months', 'description': 'seconds'}, {'measure': 'measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space', 'timeFrame': '18 months', 'description': 'mmHg'}, {'measure': 'measurement of volume of saline injected by Compuflo®', 'timeFrame': '18 months', 'description': 'ml'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia, Epidural', 'Analgesia, Epidural']}, 'referencesModule': {'references': [{'pmid': '12734154', 'type': 'BACKGROUND', 'citation': 'Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.'}, {'pmid': '12651681', 'type': 'BACKGROUND', 'citation': 'Lechner TJ, van Wijk MG, Maas AJ, van Dorsten FR, Drost RA, Langenberg CJ, Teunissen LJ, Cornelissen PH, van Niekerk J. Clinical results with the acoustic puncture assist device, a new acoustic device to identify the epidural space. Anesth Analg. 2003 Apr;96(4):1183-1187. doi: 10.1213/01.ANE.0000052382.04446.42.'}, {'pmid': '18675746', 'type': 'BACKGROUND', 'citation': 'Ghelber O, Gebhard RE, Vora S, Hagberg CA, Szmuk P. Identification of the epidural space using pressure measurement with the compuflo injection pump--a pilot study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):346-52. doi: 10.1016/j.rapm.2008.01.012.'}]}, 'descriptionModule': {'briefSummary': 'Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific, Livingston, NJ); it has therefore been made capable of controlling the pressure at the injection point and adjusting the infusion rate according to a predetermined maximum value using the registered Dynamic Pressure Sensing (DPS) technology.\n\nThe Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both visual and auditory, identifying and differentiating the different types of tissue. This safe and effective feedback helps medical personnel to identify the epidural space with greater accuracy and alerts them if the needle moves into the identified position.\n\nThe aim of the study was to verify the efficacy and usability of the Compuflo® system in a clinical setting.\n\nThe setting was the area of gynecology and obstetrics at a tertiary referral level University Hospital.\n\nAll the consecutive patients undergoing to an epidural catheter placement with Compuflo® were collected until to a sample size of 140 patients.\n\nPrimary endpoint was the number and percentage of successes in the placement of epidural catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of accidental dural punctures during epidural catheter placement; the number of attempts aimed at the correct positioning of the epidural catheter; the measurement of procedure time duration; the measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space; the measurement of volume of saline injected by Compuflo® to identify the epidural space.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the consecutive patients in gynecological and obstetric setting of a tertiary referral University Hospital submitted to epidural catheter insertion with CompuFlo® System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsigned informed consent to procedure more than 18 years of age\n\nExclusion Criteria:\n\nNO'}, 'identificationModule': {'nctId': 'NCT03503656', 'briefTitle': '"Compuflo®" in Epidural Space Identification', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas', 'orgStudyIdInfo': {'id': 'CompuFlo AOUCareggi'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CompuFlo', 'description': 'All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting', 'interventionNames': ['Device: epidural catheter placement']}], 'interventions': [{'name': 'epidural catheter placement', 'type': 'DEVICE', 'description': 'insertion of an epidural catheter using Compuflo System', 'armGroupLabels': ['CompuFlo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Alessandro Di Filippo', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}